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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

MEDLINE INDUSTRIES, LP - Northfield: Centurion Medical Kits Recalled for Defective Syringe Leaks and Breakage

Agency Publication Date: August 28, 2024
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Summary

Medline Industries, LP is recalling various Centurion procedure kits because they contain plastic syringes that are prone to leaking, breaking, and other quality failures. These kits are used for various medical procedures including circumcisions, biopsies, and retinal injections. The recall follows an FDA Safety Alert issued on March 19, 2024, regarding quality issues with these specific Caina-brand syringes.

Risk

Defective syringes may leak or break during medical procedures, which can lead to improper dosing, procedure delays, or potential injury to the patient. These issues pose a medium risk to patient health depending on the criticality of the procedure being performed.

What You Should Do

  1. Locate your Centurion procedure pack and identify the 'Pack Number' and 'Lot Number' on the external labeling.
  2. Check your kits against the extensive list of affected Lot Numbers, which include 2021092290, 2022040190, 2022011090, 2023101890, 2024021590, and others listed in the product details.
  3. Immediately stop using any procedure kits that match the affected Pack Numbers (such as CIT6920, MNS12465, MNS12670A, DYNDH1512A, CIT6720, and others) and the corresponding lot codes.
  4. Quarantine the affected kits to ensure they are not used in clinical settings.
  5. Contact your healthcare provider or Medline Industries, LP directly at 1-800-633-5463 to discuss the return of affected products and potential replacements.
  6. For additional questions or to report quality issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Quarantine and contact manufacturer

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Centurion NICU Circumcision Tray w/out Clamp
Model / REF:
CIT6920
Lot Numbers:
2021092290
2021082390
2024020290
2022042590
Product: Centurion Retinal Injection Kit
Model / REF:
MNS12465
Lot Numbers:
2022040190
2022072290
2022111890
2023042890
2023102390
2024022190
2024030790
2022022880
2021092780
Product: Centurion Arthrograph Tray
Model / REF:
MNS12670A
Lot Numbers:
2022011090
2022070690
2023022190
2023101890
2024021590
2023060290
Product: Centurion Breast Biopsy Kit
Model / REF:
DYNDH1512A
DYNDH1512
Lot Numbers:
2022121990
2023101890
2021100490
2023030190
Product: Centurion Circumcision Tray
Model / REF:
CIT6720
CIT6715
CIT7020
DYNDA2271
CIT7210
CIT6860A
CIT6720A
Lot Numbers:
2021061490
2022100490
2023010690
2023022190
2023082290
2023101890
2023102090
2023120590
2022032290
2022062290
2022071990
2022091490
2022120590
2023012490
2023030290
2023030990
2023060290
2022011080
2022122390
2023110890
2021072890
2021080390
2021083190
2021100790
2022010390
2021121590
2022042590
2022061390
2022072790
2022091690
2022110990
2023063090
2023080890
2023112990
2024020890
2024030690
Product: Centurion Nursery Circumcision Tray
Model / REF:
CIT4845
Lot Numbers:
2021122150
2022052450
2023042090
2023070390
2023081090
Product: Centurion Punch Biopsy Kit
Model / REF:
MNS8245
Lot Numbers:
2023082490
2022111890
Product: Centurion Sterile 1cc Syringe w/ Needle
Model / REF:
DYNDA2496
Lot Numbers:
2023012790
2023102590
Product: Centurion Arthrogram Tray
Model / REF:
DYNDH1446A
MNS11965A
Lot Numbers:
2020102990
2021061190
2021072690
2021083090
2022041390
2022091490
2023041090
2023040690
Product: Centurion Circumcision Kit
Model / REF:
CIT6535
CIT7095
Lot Numbers:
2024031880
2021061190
2023090580
2020121190
2022031590
Product: Centurion Circumcision Tray w/out Clamp
Model / REF:
CIT6925
Lot Numbers:
2021081190
2021090290
2022070590
Product: Centurion Umbilical Insertion Tray
Model / REF:
UVT1030
Lot Numbers:
2021072190
2022032290
Product: Centurion Medical Circumcision Tray
Model / REF:
CIT6780
Lot Numbers:
2021081650
2023092290
2021110350
2022070750
2022072150
2023030190
2024022890
Product: Centurion Shave Kit
Model / REF:
MNS8250
Lot Numbers:
2022111790

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94586
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Hospital supply channels; Medical distributors
Manufactured In: United States
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.